QC Scientist I
Research Triangle Park, North Carolina
The QC Scientist 1 is responsible for independent problem solving and the individual is specialized in at one or more discipline area within the department. The primary responsibility is to execute components of a project, both internal method improvement projects and larger customer technology/method transfer and qualification projects with the objective of revenue, profit plan, and manufacturing schedule attainment. The QC Scientist 1 supports the project management and quality systems related to the routine testing and technology transfer. The Scientist may have a lead role in method development and transfer projects from the customer to the QC laboratory. The incumbent represents the department as a discipline or technology subject matter expert, assisting with the development, trouble-shooting, improvement, and implementation of analytical methodology into the group. The individual interacts with all levels and departments within the company, assuring procedures, protocols, and project plans are suitable for implementation, that they meet the regulatory and customer requirements, and that they have continuity with existing processes and procedures.
The QC Scientist 1 creates procedures and forms for new methods, prepares periodic reports summarizing performance status of systems such as facility monitoring, method performance trending, Product Quality Reports, and other associated documentation. The individual contributes to or prepares protocols, summary reports, project plans, investigational reports, and other related quality system documentation. The position provides appropriate, innovative, and practical solutions to increasingly complex problems.
Other responsibilities and duties include but are not limited to:
- Coach analysts regarding technical issues, compliance issues related to the purpose and execution of the methods
- Assure campaign readiness regarding project milestones, STM and data form readiness, and reference material suitability
- Trouble shooting and resolution of assay execution issues
- Develops and maintains training curricula related to assigned disciplines
- Collaborates with operational groups to investigate quality-related issues
- Deviation support, Change control and CAPA’s regarding methods
- Review and inform regarding Pharmacopoeia current and proposed changes
- Manages contract laboratory testing
- Internal consultant for providing technical support for assigned discipline or technology
- Ability to facilitate cross-functional process improvement projects and transfers
- Recognizes and analyzes data trends and addresses root cause
- Collaborate with customers and colleagues
- Drive results and assure timely delivery
- Maintains expertise through personal self-improvement efforts, such as current literature searches, networking, conferences or seminars
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Coordinate and/or manage project assignments- 70%
- Support Quality System activities, such as CAPA’s, SOP development/revision/ change controls, technical report preparation, method development or verification- 30%
This position will report to a manager or director in the QC department. It is an individual contributor position.
This position does not have direct reports. It will report to a management member of the department. There is no budget or approval authority. They are responsible for contributing to the successful completion of projects that impact the profit, revenue, and supply plans.
Minimum Education Requirements
BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field
6+ years related laboratory experience (3 years required with relevant MS degree)
Specific Skills and Competencies
- Capable of high through-put and high quality, RFT work
- Certified or capable of timely certification for Yellow Belt
- Demonstrated subject matter expert in one or more analytical disciplines
- Proficient technical writing skills
- Able to make informed and timely decisions independently
- Can manage multiple assignments in timely and effective manner
- Effective communication skills with colleagues both within and outside of the department
- Capable of recognizing process gaps and implementing improvements
- Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
- Assures resolution of problems and implementation of solutions through collaboration or escalation
- Can effectively manage personal time and assigned project(s) to established timelines
- Technical, personal, and leadership skills should be career proficient.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.